1. Ensuring Safety of CFH PACS Systems Tony Newman-Sanders National Clincial Advisor, CFH PACS Programme

2. Overview Some definitions LSP Contractor Safety National CFH Safety Cluster Safety –National CCN Examples –Clinical Safety Process

3. Some definitions Safety; The process by which an organisation makes patient care safer. –It should involve: risk assessment; the identification and management of patient-related risks; the reporting and analysis of incidents; and the capacity to learn from and follow-up on incidents and implement solutions to minimise the risk of them recurring. Hazard; A situation with a potential for human injury and/or damage to property or the environment. Risk; Combination of frequency or probability and consequence/impact of a specific hazardous event.

4. Hazard Severity Severity Category Qualitative Definition CatastrophicThis category will also apply to a hazard that causes many occurrences of Major severity 3 or more fatalities 10 severe 100 Moderate 10000 Negligible Major/FatalPatient fatality. The hazard creates a situation that is inherently and immediately threatening to a patient’s life. Harm is unlikely to be prevented by Clinician. This category will also apply to a hazard that causes approx 10 Severe (100 Moderate, 1000 Low etc) SeverePermanent or long term harm. The hazard presents a serious and imminent safety risk to a patient by allowing a life-threatening situation to develop. Harm may be prevented by Clinician. This category will also apply to a hazard that causes many occurrences of Minor severity. ModerateThe hazard presents a significant risk to a patient, though not one that is immediately or necessarily life-threatening. Harm is likely to be prevented by Clinician. This category will also apply to a hazard that causes many occurrences of Minimal severity. LowExtra observation or treatment. Minimal harm. NegligibleMinimal extra observation or very minor treatment

6. Frequency/Probability >1:10 per patient year FrequentGreater than Once a day for GP 7 1:10 – 1:100 per patient year LikelyOnce a week to once a month 6 1:100 – 1:1000 per patient year ProbableOnce a year to one in 10 years 5 1:1000 – 1:10,000 per patient year OccasionalOne in 10 years to 1 in 100 years for GP 4 1:10,000 – 1:100,000 per patient year Remoteetc3 1:100,000 – 1:1,000,000 per patient year Improbableetc2 < 1:1,000,000 Per patient year IncredibleLess than 1 per 1000 GP years 1

8. LIKELIHOODLIKELIHOOD >1:10 per patient year 7 MHHHHH 1:10 – 1:100 per patient year 6 MMHHHH 1:100 – 1:1000 per patient year 5 LMMHHH 1:1000 – 1:10,000 per patient year 4 LLMMHH 1:10,000 – 1:100,000 per patient year 3 LLLMMH 1:100,000 – 1:1,000,000 per patient year 2 LLLLMM < 1:1,000,000 Per patient year 1 LLLLLM Patient Safety Risk Matrix ABCDEF Very Low LowModerateSevereMajor/ Fatal Catastro phic Consequence/Impact

9. Risk Mitigation Terminate –Avoid or eliminate –Barriers/Design//training Treat Tolerate –Acceptable level of risk Transfer –Insurance

10. LSP/ Contractors Patient Safety predominantly an LSP responsibility CFH main role is Quality Assurance. Joint end to end hazard assessment Agreeing with LSPs which risks devolve to Trusts –Board/Clinical Governance Committee –Risk Management –PACS Project Board –Clinical Director Radiology

11. Clinical Safety Organisation NHS CFH Programme Board Chief Clinical Officer, Prof Michael Thick NHS CFH Clinical Risk and Safety Team. Chair, Maureen Baker National Clinical Safety Officer Clinical Experts Project Safety Officer Technical Assurance Test Manager Clinical Risk and Safety Board Chair; NHS Trust Cinical Director

12. National CFH Safety Structure –Chief Clinical Officer - Prof Michael Thick –National Safety Officer-Dr Maureen Baker acts to provide an independent oversight of the NHS CfH Clinical Safety Management System. –Clinical Safety Group Fortnightly teleconference –National Integration Centre- Ian Harrison. Major technical brief for safety testing regularise the testing support process facilitates collaboration between the service suppliers

13. Cluster Structure CFH Clinical Lead PACS Clinical Lead Clinical Advisory Group Patient Safety Forum LSP Safety team National PACS Safety Lead

14. Central Change Control Note (CCN) ‘..new policy in relation to Contractors fulfilling their clinical risk management obligations’ ‘…to ensure that each Contractor is implementing a structured and regimented approach to clinical risk management, and is regularly monitoring and reviewing its own activities in this regard.’ …to set out the Authority's expectations of a "typical" Clinical Safety Management System, which is representative of Good Industry Practice

16. Patient Safety Assessment Workshop The key input to the workshop is the PID. Attendees typically include: Chair: Supplier Clinical Lead LSP Clinical Safety Manager NHS CFH Clinical Lead NHS CFH Release Manager A representative from NHS CFH Technical Assurance.

17. Patient Safety Assessment Interviews with appropriate accredited clinicians Interviews with message analysts Interviews with technical architects Comments and observations from the Clinical Safety Officer at NHS Connecting for Health Approved minutes of the ‘Safety workshop’ or overview of the process which took place to populate the hazard log Names, statements and dates of relevant professional experience for all participants A ‘Hazard Log’ completed using the appropriate template

18. Patient Safety Assessment Hazards in 4 main categories –End to End Clinical Process –Message Risk –Technical Risk –Patient Safety Risk NHS Connecting for Health’s ‘Hazard Checklist’ Hazard Log Raised By (Name / Job Title) Date Updated Owner Type Functional Area Summary Probability (High, Medium, Low) Impact (High, Medium, Low) Rating Safety Justification Summary of Actions and Approvals Status

19. Clinical Safety Case Inputs Patient Safety Assessment System Specification and Requirements Systems Design Documentation Message Implementation Manual Test Strategy and Plans Quality Management Documentation Structured document –Risk assessment –Mitigations

20. Safety Closure Report Input Patient Safety Assessment Clinical System Safety Case System Specification and Requirements Systems Design Documentation Message Implementation Manual Test Strategy and Plans Output- Summarise safety aspects of –Design and Build –Subsequent tests Not carried out; reasons and mitigations Inconclusive tests

21. Examples MPR annotation Radiation Dose Southern Cluster Archive Patient Record merge/misassignment Plymouth deployment. Clinical Safety Reporting Procedures